BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDX4

    MDR report key: 826841 · Received February 8, 2007

    Report

    Report Number
    826841
    Event Type
    Malfunction
    Date Received
    February 8, 2007
    Date of Event
    December 30, 2006
    Report Date
    February 8, 2007
    Manufacturer
    INVACARE CORPORATION
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    PHYSICAL THERAPIST WAS IN PATIENT'S HOME WHEN PATIENT SNEEZED AND THE POWER WHEELCHAIR SHOT FORWARD WITH PATIENT'S ARM FULLY EXTENDED. PATIENT RAMMED INTO A TV SET AND BROKE THE GLASS DOOR ON THE BOTTOM OF THE TV STAND. THE PHYSICAL THERAPIST NOTED THE CLOSE PROXIMITY OF THE JOY STICK AND THE SPEED BUTTON AND HOW EASY IT WAS TO INCREASE THE SPEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDX4 WHEELCHAIR, POWERED ITI INVACARE CORPORATION TDX4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR